
Introduction to Regulatory Affairs in Drug Development Online
5,900 kr
When developing new pharmaceuticals, the key to success is to ensure that all regulatory requirements are met throughout every stage of the research and development work. Doing it correctly from the beginning will save You time as well as money, which is often the difference between success and failure! This course targets an up-to-date overview of current regulations and how to ensure sufficient regulatory documentation in all phases of a drug’s development, with focus on the early phase. During the live online course you will be able to ask questions via chat or orally.
Who should attend?
The course is primarily aimed at you who work at a small to medium sized research based pharmaceutical company and an need overall knowledge of Regulatory Affairs. You might work as project manager, project team member, innovator and entrepreneur, academic researcher, drug developer or as business manager who work in a pharmaceutical R&D company.
Learning objectives
You will get an overview of Regulatory Affairs and an understanding of the regulatory requirements that you encounter during drug development.
Course outline
The course is structured around lectures. Participants are given the opportunity to submit questions prior to the course starting date. From the program:
- The Innovation Office at the Medical Product Agency
- Terminology and Regulations
- Marketing Authorisation Application
- Regulatory Affairs in pharmaceutical drug development
- Clinical trials – regulations and guidelines
- Product Life-Cycle Management
Instructors
The instructors are senior experts within their field. There are representatives both from Regulatory Affairs in the pharmaceutical industry as well as from the Swedish Medical Products Agency.
Time and venue
The course is held online via Läkemedelsakademin's virtual classrom in Zoom. The course starts at 09:00 and finishes at 17:00. Online participants will have access to all recorded lectures for 1 month efter the course. A link to the live online event will be sent out a few days before the course starts.
Participation fee and registration
The registration fee is 4.900 SEK until 23 Februari 2021 and thereafter 5.900 SEK. The fee includes access to all recorded lectures for 1 month, digital documentation and a certificate in digital format. All prices exclude VAT.
Other information
For information such as cancellation policy, participant list, GDPR – see “Registration Terms” to the right.
Coming events: Events in English
Date | Date | Event | Days | Location |
7 jun 2021 | jun 07 | EUFEPS Annual Meeting 2021- Bridging the gap between the patient and the product design Online | 3 | Online |
1 feb 2022 | feb 01 | 1st Nordic Conference on Computational Chemistry 2022 Göteborg | 2 | Göteborg |
Kontakt
i Stockholm AB
Box 1136
111 81 Stockholm
Besöksadress: Wallingatan 26 A
Tel: 08-723 50 00
Fax: 08-20 55 11
E-post: info@lakemedelsakademin.se
Org.nr: 556005-7043

